Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients
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The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C |
Drug: Ypeginterferon alfa-2b Drug: Pegasys |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Phase 3, Randomized, Multi-center, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Combination With Ribavirin in Chinese Chronic Hepatitis C Patients |
- Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy) [ Time Frame: 24 weeks after the end of therapy ] [ Designated as safety issue: No ]
- Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml) [ Time Frame: at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3 ] [ Designated as safety issue: No ]
Estimated Enrollment: | 726 |
Study Start Date: | April 2012 |
Estimated Study Completion Date: | April 2015 |
Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: A1(Genotype2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day
|
Drug: Ypeginterferon alfa-2b
sc, qw, 24 weeks.
|
Active Comparator: A2(Genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 800mg/day
|
Drug: Pegasys
sc, qw, 24 weeks.
|
Experimental: B1(Non-genotype 2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight
|
Drug: Ypeginterferon alfa-2b
sc, qw, 48 weeks.
|
Active Comparator: B2(Non-genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.
|
Drug: Pegasys
sc, qw, 48 weeks.
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18~65 years
- Chronic HCV infection evidence: HCV RNA or anti-HCV positive>6 months,or other evidences supporting diagnosis of chronic hepatitis C infection
- HCV RNA≥2000IU/mL, anti-HCV positive at screening
- Pregnancy tests for female patients must be negative. All patients must take effective contraception measures during the study period
- Signed informed consent
Exclusion Criteria:
- Pregnant or lactating women
- Mental or psychology disorder
- ANC<1500/mm3, or PLT<90,000/mm3, or Hb<ULN(Upper limit of Normal)
- Received interferon treatment within the previous 6 months or shown no-response to previous interferon treatment
- Co-infection with HIV, HAV, HBV, HEV
- Evidence of hepatic decompensation (e.g: Child Plug≥B, prothrombin time prolonged more than 3 seconds, TBil>2ULN, Alb<35g/L)
- Hepatocarcinoma or suffering from any other malignant tumor
- Not well controlled endocrine diseases(e.g:thyroid disfunction, mellitus mellitus)
- Significant function damage in any major organs (e.g: heart, lung, kidney)
- Involved in other investigation within the previous 3 months
- Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g: poor compliance)
Contact: Wei Lai, MD, PhD | +8610-66515490 |
China | |
Peking University People's Hospital | Recruiting |
Beijing, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Principal Investigator: Wei Lai, MD, PhD | |
Peking University First Hospital | Not yet recruiting |
Beijing, China | |
Contact: Wang Runhua +86592-6889121 clinical@amoytop.com | |
Beijing Youyi Hospital, capital Medical University | Not yet recruiting |
Beijing, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
302 Military Hospital | Not yet recruiting |
Beijing, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Beijing Youan Hospital, Capital Medical University | Not yet recruiting |
Beijing, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
First Affiliated Hospital of Jilin University | Not yet recruiting |
Changchun, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Xiangya Hospital, Central-south University | Not yet recruiting |
Changsha, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Xiangya Second Hospital, Central-south University | Not yet recruiting |
Changsha, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
West China Hospital, Sichuan University | Not yet recruiting |
Chengdu, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Southwest Hospital | Not yet recruiting |
Chongqing, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Second Affiliated Hospital Chongqing Medical University | Not yet recruiting |
Chongqing, China | |
Contact: Wang Runhua +86592-6889121 clinical@amoytop.com | |
Fuzhou Infectious Disease Hospital | Not yet recruiting |
Fuzhou, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Guangzhou Eighth People's Hospital | Not yet recruiting |
Guangzhou, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Third Affiliated Hospital of Sun Yat-sen University | Not yet recruiting |
Guangzhou, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Nanfang Hospital | Not yet recruiting |
Guangzhou, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
First Affiliated Hospital of Guangxi Medical University | Not yet recruiting |
Guilin, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Affiliated Hospital of Guiyang Medical College | Not yet recruiting |
Guiyang, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
First Affiliated Hospital, Zhejiang University | Not yet recruiting |
Hangzhou, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Second Affiliated Hospital of Harbin Medical University | Not yet recruiting |
Harbin, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
First Affiliated Hospital of Anhui Medical University | Not yet recruiting |
Hefei, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Jinan Infectious Disease Hospital | Not yet recruiting |
Jinan, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
First Affiliated Hospital of Lanzhou University | Not yet recruiting |
Lanzhou, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
First Affiliated Hospital of Nanchang University | Not yet recruiting |
Nanchang, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Second Hospital of Nanjing | Not yet recruiting |
Nanjing, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Jiangsu Province Hospital | Not yet recruiting |
Nanjing, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
81 Military Hospital | Not yet recruiting |
Nanjing, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Ruijing Hospital | Not yet recruiting |
Shanghai, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Huashan Hospital | Not yet recruiting |
Shanghai, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
85 Militay Hospital | Not yet recruiting |
Shanghai, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Shanghai Public Health Clinical Center | Not yet recruiting |
Shanghai, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Renji Hospital | Not yet recruiting |
Shanghai, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Third Affiliated Hospital, Hebei Medical University | Not yet recruiting |
Shijiazhuang, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
First Affiliated Hospital, Shanxi University | Not yet recruiting |
Taiyuan, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Tianjin Third Central Hospital | Not yet recruiting |
Tianjin, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting |
Wuhan, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting |
Wuhan, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Tangdu Hospital, Fourth Military Medical University | Not yet recruiting |
Xian, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Xijing Hospital | Not yet recruiting |
Xian, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
Hennan Provincial People's Hospital | Not yet recruiting |
Zhengzhou, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com | |
First Affiliated Hospital of Zhengzhou University | Not yet recruiting |
Zhengzhou, China | |
Contact: Wang Runhua, Ph.D +86592-6889121 clinical@amoytop.com |
Principal Investigator: | Wei Lai, MD, PhD | Peking University People's Hospital |
No publications provided
Responsible Party: | Xiamen Amoytop Biotech Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01581398 History of Changes |
Other Study ID Numbers: | TB1203IFN |
Study First Received: | February 16, 2012 |
Last Updated: | April 18, 2012 |
Health Authority: | China: State Food and Drug Administration |
Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
Peginterferon Pegasys Sustained virus response HCV |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Peginterferon alfa-2a Peginterferon alfa-2b Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on October 17, 2012